Infections, Rotavirus
Conditions
Brief summary
This observational cohort study, conducted through two existing large administrative health databases in the US (outside the Vaccine Safety Datalink) is planned to confirm the safety profile regarding lack of any association of intussusception with Rotarix within 60 days of vaccination in a real life setting (routine use) in the US. This study will also include monitoring of Kawasaki disease, convulsions, hospitalizations due to acute lower respiratory tract infections and all-cause deaths within 60-days of vaccination. This study involves three cohorts, one exposed and two control cohorts: infants who receive Rotarix (Exposed cohort) and infants who receive IPV vaccination (Unexposed cohort A and B). This is a combined prospective and retrospective cohort study. Prospective component of the study identifies and compares study outcomes following Rotarix and IPV vaccination in the Exposed cohort and Unexposed cohort A, respectively. Retrospective component of the study identifies and compares study outcomes following IPV vaccination in the Unexposed cohort B.
Interventions
OTHERHealth Insurance Database
Review of two health insurance databases in the US to determine the safety outcomes among infants who have received Rotarix or IPV vaccination.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
Yes
Inclusion criteria
For Exposed cohort: * Infants aged less than 1 year at study entry. * Infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth. * Have complete medical coverage and pharmacy benefits. * Received at least one dose of Rotarix from 1 August 2008. * Infants receiving Rotarix liquid formulation will also be eligible. For Unexposed cohort A: * Infants aged less than 1 year at study entry. * Infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth. * Have complete medical coverage and pharmacy benefits. * Received at least one dose of IPV vaccine from 1 August 2008, with or without RotaTeq vaccination. * Frequency-matched to the Rotarix cohort by gender, age at first vaccination (±1 week) and calendar quarter of vaccination within the same year. For Unexposed cohort B: * Infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth. * Had complete medical coverage and pharmacy benefits. * Received at least one dose of IPV vaccine. * Vaccinated between 1 January 2006 (inclusive) and 31 July 2008 (inclusive). * Not received any dose of rotavirus vaccination. * Frequency-matched to the Rotarix cohort by gender, age at first vaccination (±1 week) and calendar quarter of vaccination.
Exclusion criteria
For Exposed cohort: • Subject has received any dose of RotaTeq prior to the first Rotarix vaccine during the study period. For Unexposed cohort A: • Subject has received any dose of Rotarix prior to the first IPV vaccine during the study period. For Unexposed cohort B: • Subject has received any dose of rotavirus vaccines prior to the first IPV vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts | 60 days following each vaccination | Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12). |
| Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 7 days following each vaccination | Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts | 60 days following each vaccination | Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12). |
| Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts | 60 days following each vaccination | Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12). |
| Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts | 60 days following each vaccination | Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12). |
| Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 7 days following each vaccination | Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12). |
| Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts | 60 days following each vaccination | Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12). |
Countries
United States
Participant flow
Recruitment details
Subjects were identified through the automated corresponding health insurance plan databases, OptumInsight Life Sciences Research Database (from United Healthcare) and the HealthCore Integrated Research Database (HIRDSM) (part of Anthem, formerly known as WellPoint).
Participants by arm
| Arm | Count |
|---|---|
| HRV Cohort HRV (Human Rotavirus) cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans within 30 days of birth and who received at least one dose of Rotarix vaccination as part of their normal health care (with no previous dose of RotaTeq prior to or concurrent with the first Rotarix vaccination). | 57,931 |
| Concurrent Control Cohort Concurrent control cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans, who were contemporaneous with the Rotarix vaccinees and who received at least one dose of IPV (Inactivated Poliovirus vaccine) with or without RotaTeq vaccination (with no previous dose of Rotarix prior to or concurrent with the first IPV vaccination). | 173,384 |
| Recent Historical Control Cohort Recent historical control cohort consisted of infants aged less than 1 year of age, enrolled in participating health insurance plans, vaccinated with at least one dose of IPV (Inactivated Poliovirus vaccine) between 1 January 2004 (OptumInsight) or 1 January 2006 (HealthCore) and 31 July 2008 and who did not receive any dose of rotavirus vaccination during the study period. | 159,344 |
| Total | 390,659 |
Baseline characteristics
| Characteristic | HRV Cohort | Concurrent Control Cohort | Recent Historical Control Cohort | Total |
|---|---|---|---|---|
| Age, Continuous | 2.0 Months STANDARD_DEVIATION 0.7 | 2.0 Months STANDARD_DEVIATION 0.7 | 2.0 Months STANDARD_DEVIATION 0.7 | 2.0 Months STANDARD_DEVIATION 0.7 |
| Race/Ethnicity, Customized US Geographic Region Midwest | 17101 Participants | 51046 Participants | 41114 Participants | 109261 Participants |
| Race/Ethnicity, Customized US Geographic Region Northeast | 8461 Participants | 18093 Participants | 22171 Participants | 48725 Participants |
| Race/Ethnicity, Customized US Geographic Region South/Southeast | 19875 Participants | 59167 Participants | 61965 Participants | 141007 Participants |
| Race/Ethnicity, Customized US Geographic Region West | 12494 Participants | 45078 Participants | 34094 Participants | 91666 Participants |
| Sex: Female, Male Female | 27929 Participants | 83528 Participants | 77128 Participants | 188585 Participants |
| Sex: Female, Male Male | 30002 Participants | 89856 Participants | 82216 Participants | 202074 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 9 / 57,931 | 27 / 173,384 | 33 / 159,344 |
| other Total, other adverse events | 0 / 57,931 | 0 / 173,384 | 0 / 159,344 |
| serious Total, serious adverse events | 0 / 57,931 | 0 / 173,384 | 0 / 159,344 |
Outcome results
Primary
Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts
Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).
Time frame: 60 days following each vaccination
Population: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HRV Cohort | Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 1 | 0.028 Incidences/Person-Month |
| HRV Cohort | Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts | 0-59 days, Any Dose | 0.021 Incidences/Person-Month |
| HRV Cohort | Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 2 | 0.013 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 1 | 0.012 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts | 0-59 days, Any Dose | 0.022 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 2 | 0.032 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts | 0-59 days, Any Dose | 0.021 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 2 | 0.025 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 1 | 0.017 Incidences/Person-Month |
Primary
Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts
Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).
Time frame: 7 days following each vaccination
Population: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HRV Cohort | Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 0-6 days, Dose 1 | 0.000 Incidences/Person-Month |
| HRV Cohort | Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 0-6 days, Any Dose | 0.000 Incidences/Person-Month |
| HRV Cohort | Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 0-6 days, Dose 2 | 0.000 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 0-6 days, Dose 1 | 0.000 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 0-6 days, Any Dose | 0.014 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 0-6 days, Dose 2 | 0.029 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 0-6 days, Any Dose | 0.000 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 0-6 days, Dose 2 | 0.000 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 0-6 days, Dose 1 | 0.000 Incidences/Person-Month |
Primary
Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts
Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).
Time frame: 30 days following each vaccination
Population: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HRV Cohort | Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 0-29 days, Dose 1 | 0.000 Incidences/Person-Month |
| HRV Cohort | Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 0-29 days, Any Dose | 0.010 Incidences/Person-Month |
| HRV Cohort | Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 0-29 days, Dose 2 | 0.025 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 0-29 days, Dose 1 | 0.006 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 0-29 days, Any Dose | 0.026 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 0-29 days, Dose 2 | 0.048 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 0-29 days, Any Dose | 0.022 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 0-29 days, Dose 2 | 0.024 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts | 0-29 days, Dose 1 | 0.020 Incidences/Person-Month |
Secondary
Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts
Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).
Time frame: 60 days following each vaccination
Population: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HRV Cohort | Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 1 | 1.696 Incidences/Person-Month |
| HRV Cohort | Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-59 days, Any Dose | 1.518 Incidences/Person-Month |
| HRV Cohort | Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 2 | 1.278 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 1 | 1.529 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-59 days, Any Dose | 1.320 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 2 | 1.079 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-59 days, Any Dose | 1.669 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 2 | 1.260 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 1 | 2.008 Incidences/Person-Month |
Secondary
Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts
Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).
Time frame: 7 days following each vaccination
Population: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HRV Cohort | Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-6 days, Dose 1 | 1.960 Incidences/Person-Month |
| HRV Cohort | Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-6 days, Any Dose | 1.397 Incidences/Person-Month |
| HRV Cohort | Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-6 days, Dose 2 | 0.622 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-6 days, Dose 1 | 1.184 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-6 days, Any Dose | 0.932 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-6 days, Dose 2 | 0.641 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-6 days, Any Dose | 1.406 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-6 days, Dose 2 | 0.774 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-6 days, Dose 1 | 1.921 Incidences/Person-Month |
Secondary
Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts
Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).
Time frame: 30 days following each vaccination
Population: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HRV Cohort | Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-29 days, Dose 1 | 1.858 Incidences/Person-Month |
| HRV Cohort | Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-29 days, Any Dose | 1.593 Incidences/Person-Month |
| HRV Cohort | Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-29 days, Dose 2 | 1.228 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-29 days, Dose 1 | 1.523 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-29 days, Any Dose | 1.383 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-29 days, Dose 2 | 1.221 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-29 days, Any Dose | 1.788 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-29 days, Dose 2 | 1.327 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts | 0-29 days, Dose 1 | 2.166 Incidences/Person-Month |
Secondary
Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts
Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).
Time frame: 60 days following each vaccination
Population: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HRV Cohort | Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 1 | 0.047 Incidences/Person-Month |
| HRV Cohort | Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts | 0-59 days, Any Dose | 0.048 Incidences/Person-Month |
| HRV Cohort | Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 2 | 0.050 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 1 | 0.059 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts | 0-59 days, Any Dose | 0.045 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 2 | 0.029 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts | 0-59 days, Any Dose | 0.062 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 2 | 0.045 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 1 | 0.075 Incidences/Person-Month |
Secondary
Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts
Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).
Time frame: 60 days following each vaccination
Population: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HRV Cohort | Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 1 | 0.252 Incidences/Person-Month |
| HRV Cohort | Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts | 0-59 days, Any Dose | 0.230 Incidences/Person-Month |
| HRV Cohort | Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 2 | 0.200 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 1 | 0.121 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts | 0-59 days, Any Dose | 0.142 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 2 | 0.165 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts | 0-59 days, Any Dose | 0.146 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 2 | 0.174 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 1 | 0.124 Incidences/Person-Month |
Secondary
Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts
Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).
Time frame: 60 days following each vaccination
Population: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HRV Cohort | Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 1 | 0.000 Incidences/Person-Month |
| HRV Cohort | Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts | 0-59 days, Any Dose | 0.000 Incidences/Person-Month |
| HRV Cohort | Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 2 | 0.000 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 1 | 0.006 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts | 0-59 days, Any Dose | 0.008 Incidences/Person-Month |
| Concurrent Control Cohort | Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 2 | 0.011 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts | 0-59 days, Any Dose | 0.009 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 2 | 0.004 Incidences/Person-Month |
| Recent Historical Control Cohort | Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts | 0-59 days, Dose 1 | 0.014 Incidences/Person-Month |